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510(k) K771588

PLATELET CONTROLS NORMAL & ABNORMAL by Dade, Baxter Travenol Diagnostics, Inc. — Product Code GJP

K771588 is an FDA 510(k) premarket notification submitted by Dade, Baxter Travenol Diagnostics, Inc. for the device "PLATELET CONTROLS NORMAL & ABNORMAL". The FDA issued a decision of Substantially Equivalent on August 25, 1977. The device falls under product code GJP (Control, Platelet), a Class II device regulated under 21 CFR 864.8625. Dade, Baxter Travenol Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1977
Date Received
August 18, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Platelet
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by Dade, Baxter Travenol Diagnostics, Inc.

  • K800296 — WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 (March 5, 1980)
  • K792606 — WHOLE BLOOD PLATELET CONTROL NORMAL, (February 13, 1980)
  • K792723 — BLOOD FLUID FILTERS (January 21, 1980)
  • K792607 — T3 UPTAKE (T3U) REAGENTS (January 16, 1980)
  • K792443 — TSH RADIOIMMUNOASSAY (December 27, 1979)
  • K792442 — FERRITIN RADIOIMMUNOASSAY (December 18, 1979)
  • K791922 — HARLECO BRAND CLINICARD LIPASE TEST SET (November 27, 1979)
  • K792183 — DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO (November 13, 1979)
  • K790767 — IMMU-TEK AUTOMATIC CENTRIFUGE (May 23, 1979)
  • K790776 — DADE LOW IONIC STRENGTH SOLUITION (LISS) (May 23, 1979)

Other clearances for product code GJP

  • K880608 — MSI-PC (March 21, 1988)
  • K823930 — HEMATOLOGY QUALITY CONTROL MIXTURE (February 1, 1983)
  • K770655 — LATELET DETERMIBATION KIT, UL 800 (June 24, 1977)

FDA data resources